FDA Inspection 1192137 — Coapt LLC
The FDA completed an inspection of Coapt LLC on November 2, 2022 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |